Standing Committee G

Mrs. Irene Adams

Human Tissue Bill

Clause 10 ordered to stand part of the Bill.

Schedule 2 - The Human Tissue Authority

Andrew Lansley: I beg to move amendment No. 6, in
schedule 2, page 38, line 13, at end insert—
 (3) Subject to the requirements of sub-paragraph (2) above, the Secretary of State shall exercise his power to appoint members of the Authority to secure that the Authority will also consist of members who have relevant expertise in the activities to be regulated by the Authority.'.
 Having completed part 1, we move to the establishment and composition of the Human Tissue Authority. The amendment is designed to secure that, in exercising the power of appointment that is given to the Secretary of State under sub-paragraph (1)(b), he will do so in a way that ensures that the authority consists of members who have relevant expertise in the activities to be regulated by the authority. I should have said ''will also consist'', lest it be thought that we are intending that the authority should consist only of members who have relevant expertise. 
 I am sure that the Committee will recognise that worry has been expressed that schedule 2 has a skeleton structure. It tells us about the constitution of the authority, but little about the way in which it will conduct itself. It has pretty much of a pro forma, constitutional style. Its membership is a key aspect of the matter. In theory—I am sure not that it is so in practice—the Secretary of State can under paragraph 1 appoint to the Human Tissue Authority people who have no relevant expertise in such activity. 
 Members of the Committee can in various ways attest to the value of some expertise, although not all of us have expertise in the activities of the authority. It would be useful if some authority members had such expertise. The authority should comprise a mix of laypersons, those with clinical or scientific expertise and members of the public who have had unhappy or distressing experiences. It is certainly my experience of the support network in Cambridge that such people have contributed substantially and responsibly to the consultation processes that are now leading to the establishment of the Human Tissue Authority. When we consider relevant expertise, we must bear in mind that not only expertise but experience is relevant. 
 The purpose of the amendment is to explore the Government's intentions for the establishment of the authority. Without stretching your consent too far, 
 Mrs. Adams, I hope that we can explore the timetable for the establishment of the authority and what processes the Government have in mind for setting up a shadow authority, so that when the HTA begins its work, it might be able to do so with, for example, a code of practice in place. Representations that have been made to me have concerned not only the expertise available to the authority and its ability to do its job, but the fact that members of the relevant medical and scientific communities should have access to the codes of practice in as near as final a form as possible, and as soon as possible.I hope that the amendment commends itself to the Committee and that it is the Government's intention that members of the authority should include those with relevant expertise. Such expertise might, for example, include those from the medical community who are aware of the processes of taking consent and working with families and patients, people from the Royal College of Pathologists or those who have expertise in the scientific and research applications of retained organs and tissues. We shall discuss the boards of the inspectorate later, especially in relation to the Royal College of Pathologists and its special role. 
 I do not want the implications for the biotechnology industry to be left out of account—we will discuss that later. The Human Tissue Authority will be very concerned with the issues of licensing and of trafficking and commercial dealings. For that reason, too, there is an argument for those with relevant expertise to be included. 
 Lest there be any misunderstanding, I should say that the subsequent requirements relating to the absence of conflicts of interest would obviously apply to those with relevant expertise; they would not be persons who had interests that were prejudicial to their membership of the authority. That may make it more difficult to appoint people with current clinical or research interests. However, I am sure that we can devise arrangements that avoid any decisions being made that would bear on an individual's current research interests. That happens in many circumstances: for example, research ethics committees and research councils often include people who have research projects that could be directly relevant to their membership, but arrangements can be made to exclude them from any decisions where a conflict of interests might arise. 
 I hope that the amendment commends itself as one that the Government might adopt. In any case, it is important to understand at this stage their intentions for the composition of the authority. I hope that they will agree that the Secretary of State will take into account some of the considerations that I have mentioned. It might also be helpful at the outset of our discussion of schedule 2 for the Committee to be told what timetable the Government have in mind and what process there is for establishing the Human Tissue Authority in its shadow form before it takes up its role.

Richard Taylor: I support the hon. Member for South Cambridgeshire (Mr. Lansley). The Government are right strongly to
 support the interests of relatives and patients, but I remind the Committee of comments in the General Medical Council briefing:
 ''The GMC is concerned about the balance that needs to be struck between the rights of patients and their families and the reasonable practice of medicine.'' 
There should be more in the Bill that states that people with knowledge of research practices and pathology should be on the Human Tissue Authority, particularly when it comes to discussing the codes of practice. 
 We have received letters from other authorities. The hon. Member for South Cambridgeshire mentioned the Royal College of Pathologists. Cancer Research UK feels that somebody from the research community must be included. The Council of Heads of Medical Schools thinks that there must be appropriate expertise in the use of human tissue for research. I support that. It is right that, as the Government say, lay members should be in the majority, but there must be a sufficient presence from the knowledgeable community of pathologists—I was going to say pathological community, which would have been a bad way of putting it—and the research community to ensure that reasonable practice of medicine is still possible.

Rosie Winterton: I completely understand Opposition Members' points about the need for appropriate expertise on the authority, but the amendment is unnecessary. However, I want to use this opportunity to emphasise that we support people with appropriate expertise being on the authority.
 The Bill provides for the authority to have not less than half lay membership. It is intended that, as in all arm's length bodies in specialist areas, the non-lay membership will comprise people who have relevant expertise. It is clear that the Human Tissue Authority would not be able to function properly if its members did not have suitable expertise. We have provided for the authority to have a majority of lay members, because it is important that all concerned are able to improve public confidence. There will be representation from professionals with an interest in using tissue, but we need to ensure that they do not dominate the regulatory body. 
 It is important that there is a range of expertise among the other members, because the authority's remit is relevant to such areas as transplantation, anatomy, pathology, surgery, tissue banking, and so on. I do not want that list to sound exhaustive, because it would be unfortunate to leave out any group that felt that it should be represented. A very wide group of people could be included. One difficulty with the amendment is that it might allow for every sub-speciality to lay a claim to having a member on the authority by virtue of their expertise in one of the matters regulated. People with a variety of expertise will be needed, but they will be appointed to the authority on merit in accordance with the Nolan principles. The numbers of people who are needed and 
 how the relevant expertise is covered will be a matter of judgment. Members of the authority will, perhaps, be appointed through the NHS Appointments Commission, or there may be a recruitment exercise.

Andrew Murrison: I am glad that the Minister has dealt with the subject of numbers, if only peripherally. I hope that she agrees that it is important for her to give us some idea of the size of the Human Tissue Authority. At the moment we have only an inkling of the possible numbers from a reference in clause 17(3) to an appeals committee of five.

Rosie Winterton: Many of the structures of the Human Tissue Authority are based on the Human Fertilisation and Embryology Authority, which is made up of approximately 20 people. It will be necessary to make a judgment about exact numbers after consultation—but that is a possibility. We will consider other bodies with similar responsibilities. We may consider whether there should be a similar number of people to the HFEA, but I would not like completely to tie that down, because it is important that we ensure that we have the relevant numbers of people with expertise. I assure hon. Members that organisations and others with an interest in the work of the authority will be made aware of all vacancies, so individuals with relevant expertise will have the opportunity to apply.
 The hon. Members for South Cambridgeshire and for Wyre Forest (Dr. Taylor) raised the issue of when the authority and the shadow Human Tissue Authority will start work. If we were to anticipate Royal Assent before next summer, we would need a period before fully implementing the legislation to prepare any necessary regulations and orders, and to allow the practical aspects, such as the licensing procedures, to be developed. Full implementation is likely to occur in 2005, but we anticipate a shadow authority getting to work quite quickly. We in the Department can start preparing the shadow Human Tissue Authority very soon. We would hope to see drafts of the codes, to which the hon. Member for South Cambridgeshire referred, beginning to emerge over the coming year. The shadow authority will start to prepare the licensing and inspection procedures and the codes of practice. We will want that shadow authority to consult family groups, professional groups and so on, and to start to set up the infrastructure for the new authority.

Evan Harris: The Retained Organs Commission finishes in a couple of months' time. Clearly, the Human Tissue Authority will not be up and running by then, possibly not even in shadow form. Who will carry on the commission's work, which will still need to be done, during that interim period?

Rosie Winterton: The Retained Organs Commission, as the hon. Gentleman says, is due to close on 31 March. However, the Department of Health is in close contact with the commission about the process for handing over its work in the first instance to strategic
 health authorities. There will certainly be continuity with the central telephone advice line. At the moment, the commission is working with strategic health authorities so that they follow its guidance on inquiries from families and so on. The hon. Gentleman will know that a lot of expertise has been gained during the past three years on how to deal with such sensitive issues.

Andrew Lansley: I share the concern of the hon. Member for Oxford, West and Abingdon (Dr. Harris). The proposition is that the responsibilities and expertise acquired by the Retained Organs Commission should be let go, and that much of it should be recreated in the Human Tissue Authority after an intervening period in which strategic health authorities try to deal with the same issues in the same way. On the face of it, that is not the best way of proceeding. It seems that we are dispersing responsibilities around the country and gathering them back together at the Human Tissue Authority. Is there not a case for continuing the work of the Retained Organs Commission until the shadow Human Tissue Authority can pick up its responsibilities and some of the staffing at the centre?

Rosie Winterton: I understand the hon. Gentleman's point. However, we have to be clear about what the Retained Organs Commission will be able to do and what one would expect it to be doing at this stage, given the work that has already been done. We are talking about the retention of organs and tissue that has taken place over a number of years. The job of the Retained Organs Commission is to ensure that, wherever possible, retained organs and tissue are returned as quickly as possible—if that is appropriate and what families wish—or that such organs and tissue are retained for medical research and so on. We want that to continue.
 The Retained Organs Commission is talking with trusts and strategic health authorities at a local level—the level at which we feel that decisions and guidance can be most adequately dealt with. It is not a question of handing responsibility over. It is appropriate that such expertise is passed on to individual trusts and to strategic health authorities so that the casework and the support for families also transfers to the local level. Much of the work has been completed, but there will be advice and draft guidance, which the shadow Human Tissue Authority can pass on if necessary. Initially, it is most appropriate for trusts and strategic health authorities to deal with and build on the valuable expertise that the Retained Organs Commission has established.

Andrew Murrison: I am a little concerned because the Retained Organs Commission will be a repository for the experience of the civil servants working for it. Does the Minister envisage that expertise going elsewhere and individuals being reappointed? The natural corollary of what she is saying is that those people will be subsumed within the shadow authority and ultimately the HTA. However, under the scheme that
 she outlined, those civil servants will presumably be reappointed to areas completely outside the sphere, and that would represent a huge loss of experience.

Rosie Winterton: As I have said, the Department will continue to work closely with trusts and strategic health authorities to ensure that they are able to follow the guidance that the commission will pass on. The scheme is an appropriate way to continue the commission's work, and some civil servants involved with it may join the shadow authority. We have been working closely with the commission to ensure that we are fully aware of the guidance and the expertise that it has accumulated and will disperse to trusts and strategic health authorities.
 I hope that that provides reassurance, both on the timetable for the establishment of the shadow authority, and on the fact that we understand the need for the authority to have proper expertise. The proposals outlined in the Bill are the best way to secure that, and I hope that the hon. Member for South Cambridgeshire will withdraw the amendment.

Andrew Lansley: I am grateful to the Minister for responding to the range of subjects that were raised. I shall deal first with the timetable. Given that the shadow authority may be established in the summer if the Bill receives Royal Assent before the summer recess, I am not entirely persuaded that it is sensible for all the commission's functions to be dispersed, although I realise that some might be held by the Department of Health rather than the strategic health authorities. The authority should not necessarily work with families individually in the longer term; trusts should take on that responsibility.
 If the shadow authority will be functioning later this year, with a view to becoming a legal body in 2005, there will be an intervening period during which codes of practice and the like will be established. As we have already discovered, and will discuss further, the codes of practice are instrumental to the authority's functioning. It is obviously in the interests of the medical and research communities that the codes of practice are available as early as possible, and in a form that is unlikely to change repeatedly subject to consultation, otherwise that would create confusion. 
 I want to ensure that substantive appointments are made to the authority which are likely to subsist, so that those making decisions are likely to have to live with them and follow them up once the body is formally established. That means getting on with the job fairly quickly. 
 The Minister directed us to look at the structure of the Human Fertilisation and Embryology Authority. I have seen several links between this Bill and the legislation governing that authority which suggest that they operate in similar ways. On matters such as transparency, which we will discuss, the HFEA is a good example for the Human Tissue Authority to follow. 
 On membership and numbers, it is interesting that last year we discussed the structure of the independent regulator for foundation hospitals. I was in an adjacent Committee Room, in which the Department 
 of Health sternly insisted that the regulator could not be more than one person, although it finally bent to the idea of two or three. It said that the only way to deliver executive authority properly was through one person. That number has now increased to 20, which is going from the ridiculous to the sublime, depending on which part of the Department of Health one is dealing with. [Interruption.] Perhaps it depends on which Minister one is dealing with. 
 Twenty people seems to be a large authority, but if—as the Minister says—several members of the Human Tissue Authority will have relevant expertise, many people in the areas that I mentioned should be satisfied. If the authority were reduced to a smaller number of people, with only a few having relevant expertise, it would have difficulties in representing the areas of interest to which the hon. Member for Wyre Forest and I referred. We want to ensure that those areas of expertise will be represented. 
 As long as we have the Minister's assurance that that is the intention and that it will be delivered in due course, there is no value in pressing the matter. On that basis, I beg to ask leave to withdraw the amendment. 
 Amendment, by leave, withdrawn. 
 Question proposed, That this schedule be the Second schedule to the Bill.

Evan Harris: I have one question for the Minister about holding meetings in public. The HFEA, to which she previously referred, is pleased to be holding in public those parts of its meetings that can be held in public. I welcome that development, but that authority has been in existence for many years. There is no reason why the Human Tissue Authority should take several years to ensure that it has a default policy of holding in public all of its meetings that do not involve confidential business. Information should be available on its website so that members of the public and interested parties may attend to see the workings of the authority.

Rosie Winterton: I hope that I can reassure the hon. Gentleman. If no confidential business needed to be discussed in private, I would hope that meetings would, as far as possible, be held in public.
 Question put and agreed to. 
 Schedule 2 agreed to.

Clause 11 - Remit

Andrew Murrison: I beg to move amendment No. 28, in
clause 11, page 9, line 28, after 'for', insert 'the'.

Alan Hurst: With this it will be convenient to discuss the following:
 Amendment No. 83, in 
clause 13, page 10, line 35, after 'from', insert 'paragraphs (d) to (f)'. 
Amendment No. 106, in
clause 29, page 19, line 19, leave out from 'activity' to end of line 21. 
Amendment No. 129, in 
clause 33, page 23, line 6, leave out subsection (3).

Andrew Murrison: The amendments deal with the vexed question of qualifying museums, which appear to have assumed a special status in the Bill. The explanatory notes tell us that qualifying museums are those that are open to the public and do not make a profit. Because of that, they appear to have been given several attributes and exclusions that will make their life much easier. We may all say that that is jolly good, but the Bill is about controlling the way that organs and bodies are handled, and it seems extraordinary that those museums should be excluded.
 One concern that has been raised by members of the general public relates to the activities of Professor Gunther von Hagens and his ''Bodyworlds'' exhibition. At the very least, that was controversial. It is a matter of opinion as to whether it offended the public sense of good taste or decency, and although I do not think that any Opposition Members would want to see those activities banned out of hand, there is a feeling that they need to be regulated. Of all the activities that we are discussing, this one needs the light of scrutiny poured upon it. It is unusual and new, at least in terms of this century and the last, so we need to delve into it more closely. We need to ensure that the inspectorates that will be set up under the Human Tissue Authority can scrutinise what is going in exhibitions such as ''Bodyworlds'', and in other activities that could spring up. 
 We understand that the activities of Professor von Hagens were legally controversial at the time. It therefore seems strange that the Bill has not grasped the opportunity of defining what is permitted and what is not. In respect of the other activities under discussion, and in the context of a qualifying museum, one could say that things are being allowed to become institutionally lax. 
 The group of four amendments tabled in my name and that of my hon. Friends the Members for South Cambridgeshire and for Rayleigh (Mr. Francois) would degrade the special consideration that qualifying museums are given in the Bill. I hope that the Minister will tell the Committee why those museums, which are defined by having public access and being not for profit, are given such special handling. 
 Amendment No. 28 is a presentational amendment. It would insert the word ''the'' in connection with purposes. We merely want to quiz the Minister on her grammar. It seems that ''the'' would improve the way that the Bill reads. I would be interested to know whether the Minister agrees with our interpretation. 
 The remainder of the amendments stem from what I have been saying about qualifying activities, and probably do not need to be explained in any further depth. I draw the Minister's attention to amendment No. 83, which would clamp down on the exemptions that can be enjoyed by qualifying museums. It 
 mentions specifically paragraphs (d) to (f), which refer to activities about which we would be particularly concerned. 
 Amendment No. 106 would delete clause 29(3)(b) by removing the exemption that qualifying museums have under clause 29. Similarly, amendment No. 129 would delete the exemption that qualifying museums have from the scrutiny of the inspectorates of anatomy and pathology. In the case of such scrutiny by inspectors, I can think of no more compelling an argument than that they should be able to enter qualifying museums, especially given the novel activities that we have seen over the past few years—I am thinking in particular of ''Bodyworlds''. 
 It is extraordinary that the Bill should specifically state that those museums are excluded from the inspectors' remit. We do not for one moment say that they should be subjected to the increasing bureaucracy that would come with the inspectors, but it is remarkable that they should be specifically excluded from their scrutiny. Indeed, I hope that the inspectors will be able to help qualifying museums to determine how they might proceed with their exhibits. The amendment is meant to be helpful.

Evan Harris: Will the Minister make clear her perspective on exhibitions such as ''Bodyworlds''? I do not demur from the general thrust of what the hon. Member for Westbury (Dr. Murrison) said, but where certain conditions are met it should be possible for adults to view displays such as those at ''Bodyworlds'' and to watch anatomical examinations. I imagine that those qualifying conditions would involve the clear consent of the people concerned, as in the consent provisions in part 1, and the licensing of the premises and of the person in charge.
 I should like the Minister to confirm that the Government will seize the opportunity presented by the Bill to make it clear that they will not censor properly regulated public displays of human anatomy which adults in this country might wish to see. Indeed, engaging in an informed discussion about what happens to our bodies after our death can demystify aspects of human anatomy. Clearly von Hagens's public post mortem or autopsy was not ideal from many points of view. This is an opportunity to establish what is permitted and how such activities will be regulated rather than to use the measure as an excuse to ban such displays completely.

Harry Cohen: I, too, welcome the amendment and the fact that it seeks clarification from the Minister about exhibitions such as ''Bodyworlds''. As has been stated, the clause puts qualifying museums, which are categorised as not-for-profit museums, outside the authority's remit. I agree with the point made by the hon. Member for Westbury that some of those museums could probably get good assistance from the inspectorate or the authority on how to exhibit their items. Although they will be outside the authority's remit, ''Bodyworlds'' would presumably have fallen within it because people paid to see it; it was done for profit. I know that about
 500,000 people saw that exhibition in this country, and on the whole they thought it a worthwhile exhibition. I found it beneficial.
 I should like to know how the authority will judge an application like this when it comes before it. Clearly, the Bill's emphasis is on approval and consent, and in this case that would have applied to how the bodies were obtained. I asked the Library to obtain some information for me about the ''Bodyworlds'' exhibition, and I will quote from an interview that Professor von Hagens gave about this time last year. He was asked: 
 ''Is it true that you were illegally supplied with bodies from Novosibirsk, Siberia? If so, are any of them on show in London?'' 
He replied: 
 ''No. All these allegations are just satisfying the old tradition of mixing body-snatching with anatomy. I agreed that preserved specimens would be sent from Novosibirsk to Heidelberg for plastination and then they would be sent back to Novosibirsk University. They were exported legally— I got the signature of the local customs official and the director of the university. I did not need the consent of the body donors because in Russia, bodies that are not claimed within a certain period of time are transferred by law to anatomy departments. The same law exists in the United States, for example in Maryland. Since the bad publicity, I have cancelled the whole agreement. All the body donors in the exhibition have given their consent.'' 
The case concerning whether those bodies were obtained legally still continues in the Russian courts. Originally, those supplying them were found not guilty, but now the case is being re-examined. However, the key point in that case was that the law on consent and approval is weaker in Russia and apparently, as Professor von Hagens said, in the United States, and presumably in many other parts of the world. I believe that he is currently having an argument about body parts supplied in China. 
 Although it is right for us to put the emphasis on consent in the Bill, it will not be possible to tighten the law in relation to an exhibition of that sort unless Professor von Hagens obtains more bodies from voluntary donors in the west, as he has talked about doing. I think that the Human Tissue Authority could have a role in examining that aspect. 
 There are two other aspects that I want to mention, other than the question of where the bodies came from. One is art. ''Bodyworlds'' was an exhibition that was intended perhaps to shock, to entertain and to make people think. In my view, that is a legitimate purpose, and I wonder how the authority would judge it. Would it have the power to call in art critics to examine that aspect if it were considering such an application?

Evan Harris: I do not think that authorities involved in regulation should be making subjective judgments on artistic merit. If something is, in principle, lawful, it is up to the visiting public to decide on its merits. If it is a lousy exhibition with no artistic, entertainment or educational value, one relies on the paying members of the public who visit it to make that decision.

Harry Cohen: I hear that point, but my question on the amendment is whether the authority will consider the art aspect at all.

Andrew Murrison: Does the hon. Gentleman think that Damien Hirst might be co-opted on to the authority?

Harry Cohen: That relates to the point that I am making: how will the authority deal with the art aspect—assuming that that is included in its remit—of such an application? Will it co-opt someone like Damien Hirst, or other critics? Is the Minister saying that the authority should not examine the art aspect, but just consider where the bodies came from and the consent issue, which is the other main theme of the Bill? I do not think that that approach would work for such exhibitions, and it would therefore need to be expanded.
 The other point that I was about to make was that exhibitions such as ''Bodyworlds'' have a clear knowledge factor. The exhibition was presented—I was almost going to say that this was the most boring part—as an anatomical exhibition about how different parts of the body work. That was explained in great detail; it was great for a medical student or anyone interested in biology. There might be a case for showing such an exhibition, and perhaps the authority will consider that aspect, or will it be limited to what is rightly the core of the Bill—consent and the origin of body parts? In a groundbreaking exhibition such as this, the authority's remit must be wider. I shall be interested to hear what the Minister says about that.

Rosie Winterton: This has been an interesting and wide-ranging debate, raising a number of questions about the authority's ability to judge the artistic relevance of different exhibitions. I shall come back to that later. I know that my hon. Friend the Member for Leyton and Wanstead (Harry Cohen) went to the von Hagens exhibition, which he mentioned on Second Reading.
 I shall first address the individual amendments and then explain how we intend to address the issue of the qualifying museums. The hon. Member for Westbury said that amendment No. 28 was perhaps a test of grammar; he believes that it would correct a perceived technical flaw in the Bill. However, the problem is that the amendment would limit the clause's flexibility. As drafted, the clause covers any purpose of a qualifying museum, rather than promoting any particular purpose. We do not feel that the amendment is required. 
 Amendment No. 83 would bring qualifying museums within the licensing regime in respect of post mortems, anatomical examination and the removal of material from the body of a deceased person for use for a scheduled purpose. As members of the Committee know, we all agreed on Second Reading that the Bill was a response to the distress of people whose deceased relatives had had their organs retained for research without the families' consent. At the same time, it is also an attempt to create a framework to support research and development in science and medicine. 
 Museums have substantial holdings of human remains of historical or archaeological interest, so they deserve special consideration in the Bill. The treatment of human remains held by qualifying museums is not different in ethical terms from that in other sectors that 
 might be affected. Although museums do have substantial holdings of human remains—in a survey commissioned by the Department for Culture, Media and Sport in 2002, museums in England alone were found to have more than 61,000 remains in their care—the vast majority of those remains date from before 1900. Many are a great deal older than that: there are archaeological remains ranging across thousands of years, including Egyptian mummies, Lindow man—the body of a prehistoric human found in Cheshire which had been preserved in a bog—items, such as pipes, made from human bones, and reliquaries. 
 The treatment and use of human remains in museums is the subject of a report by the working group on human remains, which was set up by the DCMS in May 2001 but published its findings only in November 2003. Following on from that report, we plan to launch, in the next few weeks, a consultation on the treatment and use of human remains in museums. The consultation will specifically address whether, and in what manner, museums should be brought within the remit of the Human Tissue Authority and the licensing regime, which we could do after the consultation by using the order and regulation-making powers in clauses 11(4) and 13(5). 
 Assuming that the Bill is passed, we would be able to use its powers to bring museums within the remit of the Human Tissue Authority and the licensing regime. However, we would do that only in a way that is sensitive and appropriate to the needs of the museum sector, working in the context of a Bill that is aimed mainly at modern or recent remains that have been obtained in a medical or clinical setting. 
 We are undertaking the consultation exercise to assess the manner in which the licensing regime should apply to qualifying museums. The consultation will also address the financial impact on the museums sector of bringing it within the licensing regime. Although we are confident that a museum such as the Natural History museum could afford to be under the licensing regime, we need to establish the impact that the change might have on smaller institutions. 
 One example of such an institution would be the Old Operating Theatre museum in Borough high street, London. It has only a small number of staff and limited facilities, but houses the only surviving Victorian operating theatre, which it makes available to the public. The Committee will understand that we want to make a proper assessment of how such museums would be affected by the licensing regime. I understand the points that have been raised, but that is how we are planning to act and, as Members will know, the Bill contains powers to make that possible. 
 I turn to the detail of amendment No. 83. As the hon. Member for Westbury said, it is designed to prevent the scenario suggested on Second Reading in which Professor von Hagens or someone like him collaborated with a qualifying museum in putting on exhibitions or demonstrations and thereby avoided regulation. 
 First, that scenario is unlikely. Professor von Hagens operates a commercial enterprise and makes a profit by charging for access to his exhibitions. To escape regulation, he would need to become a qualifying museum. He would be required to maintain a permanent collection that was open to the public and to become a not-for-profit enterprise. It would not be sufficient for him merely to make use of rooms in the grounds of a qualifying museum. Even if he performed a public autopsy in such grounds free of charge, he would still fall under regulation unless he could establish that he maintained a permanent collection available to the public on a non-commercial basis. We certainly do not think that Professor von Hagens would willingly give up all his profits, particularly in the light of the very expensive process of plastination. 
 Secondly, the amendments do not cover the full scope of von Hagens' activities. They cover the performance of a public autopsy in a qualifying museum, but leave open the possible display of plastinated corpses—which is von Hagens' main activity and source of income—particularly if performed in a qualifying museum.

Andrew Murrison: I might have misunderstood. Just for clarification, is the Minister saying that, hypothetically, Professor von Hagens would not be able to find a qualifying museum in this country in which to mount one of his displays or to carry out some of the activities that he carried out a couple of years ago? Is she saying that he would have to have his own museum set up legally as a separate entity?

Rosie Winterton: It would not be sufficient for Professor von Hagens simply to make use of the rooms in a museum. He would have to have a permanent collection that was open to the public, and that itself would have to be licensed.
 I reassure the Committee that even if museums are not brought under the licensing regime—as I have said, we are consulting on the issue; we want to be quite clear about the implications for the qualifying museums—if a qualifying museum were somehow to stage such an exhibition, the Government would certainly use the powers under subsection(4) to bring the exhibition within the licensing regime. We see that as the way forward. 
 My hon. Friend the Member for Leyton and Wanstead talked about the source of bodies and unclaimed bodies going to the anatomy department as in Russia. It is quite clear that, because of the strict consent required—in writing, witnessed, and so on—the Bill makes it impossible for that to happen in this country. In addition, the Human Tissue Authority will establish conditions on import and public display so that we can make sure that appropriate consents have been given. 
 We have to recognise, as I said in earlier debates, that there may be different ways of consent being given in different countries and that we cannot necessarily apply exactly the same standards, but because of the regulation of imports, the Human Tissue Authority would want to see some evidence of consent. I also reassure my hon. Friend that we are not talking about 
 banning public display. We want matters to be appropriately regulated, and for the consent for public display to be clear and explicit. 
 I turn to the question of art. The Human Tissue Authority will regulate the display of human tissue and license it in certain circumstances, but the Government are not seeking to determine what is or is not art. We do not envisage that being in the remit of the Human Tissue Authority.

Evan Harris: Will the Minister respond to the question I asked? How does she see the Human Tissue Authority acting on the question of public displays? I hope that, assuming the appropriate consent and that all the licensing requirements are met, she envisages no problem with a display, including that of a publicly visible autopsy that adults in this country can see. The Government were quite negative about the matter at the time, perhaps for reasons to do with consent.

Rosie Winterton: The hon. Gentleman has hit the nail on the head. The issue was about consent. We have taken the opportunity of this Bill to make it very clear that we require high levels of consent—in writing, witnessed, and so on—that somebody wishes their body to be used for such purposes. However, as I have said, we are not seeking to ban such practice; we are simply seeking to ensure that it is properly regulated and licensed.
 Amendment No. 106 would remove the ability of qualifying museums under clause 29(3)(b) to acquire human remains by purchase without committing a criminal offence other than by seeking designation from the Human Tissue Authority. We adopted the policy in that subsection because of the differences, which we have already discussed, between the museums sector and medical and scientific facilities, which are the main target of the Bill. Clause 29 is primarily aimed at prohibiting the trade in organs, but museums do not sell or buy organs. They have no purpose in doing so, and nor would they have the facilities even if they decided to do so. The intention of the Bill is to maintain the status quo and to enable qualifying museums to continue to acquire in connection with their publicly available collection policies in the certainty that they will not be committing a criminal offence by so doing. Although much of what museums would try to buy, such as Egyptian mummies, has been subject to the application of human skill, and so falls outside the restriction, museums are interested in the acquisition of other categories of human remains that are not widely available and which they may conceivably have to acquire by purchase. The Natural History museum in London, for example, might wish to acquire a ''bog man''. 
 Amendment No. 129 would delete subsection (3) of clause 33, thereby bringing museums into the remit of the inspectorate of anatomy and pathology. The issues and the reasons that we oppose the amendment are almost identical to those I set out in replying on amendment No. 83, so I will not go through them all again. I reiterate just that we will be launching a consultation in the next few weeks to address the issue 
 of whether museums should be brought within the licensing regime, and that because the working group on human remains produced its report only in November, we have not had time fully to consult the museums sector on the proposal. It would not be appropriate to bring the qualifying museums under the licensing regime immediately. 
 Although we certainly share the concern expressed by hon. Members that Professor von Hagens should not be allowed to exhibit or stage demonstrations unregulated, the order and regulation-making powers in the Bill give us the facility to bring Professor von Hagens into regulation and within the remit of the inspectorate of anatomy. That is a much more sensible and cautious way to proceed at this stage. 
 We think that this is a much more sensible and cautious way to proceed at this stage. I hope that with those reassurances, hon. Members will feel able to withdraw their amendments.

Andrew Murrison: I am very grateful to the Minister for that comprehensive account. I am reassured because we seem to be singing from the same hymn sheet. The amendments may come to pass as a result of the consultation exercise that she told us about today, and I welcome that necessary exercise. It is a pity that it was not conducted before we drafted the Bill. I am also reassured by the Minister's assurance that she is prepared to use the powers granted to her under clause 11(4) in the event of someone like Professor von Hagens needing to be investigated and his activities needing to be restricted in some way. With that in mind, I beg to ask leave to withdraw the amendment.
 Amendment, by leave, withdrawn.

Clause 11 - remit

Andrew Lansley: I beg to move amendment No. 29, in
clause 11, page 9, line 30, leave out subsection (4).

Alan Hurst: With this it will be convenient to discuss the following:
 Amendment No. 30, in 
clause 11, page 9, line 30, leave out from 'order', to 'to' in line 31 and insert 'vary, omit or add'.

Andrew Lansley: Amendment No. 29 effectively would delete subsection (4), the purpose of which was initially to test the question of what the Ministers had in mind by adding to the activities. We have learned from the previous debate what Ministers have in mind as a possibility of adding to the activities within the remit of the authority.
 On amendment No. 30, there remains the substantive question; why it is the Government's intention to have the power to add to the activities within the remit of the authority, but not to be able to vary, omit or add to activities in relation to other matters, such as scheduled purposes within the remit 
 of the authorities, as we have seen illustrated? Although there were changes in the scheduled purposes, by extension they would automatically change so far as the remit of the authority was concerned. It may be that as time goes on and in ways we cannot yet determine, the authority will see a necessity not only for additional activities, but to vary the terms in which its activities are defined, or even omit some of those activities. 
 In so far as the scientific and research community and the commercial biotechnologies industries are concerned, the licensing regime and the requirements of the authority create some burdens. It is desirable to contemplate, in the long run, that the authority may wish to pursue a deregulatory path at some point. It may be that it will want to retain activities within its remit but behave in a different way. However, current legislation may not allow it to do so. It may be that the only way in which to pursue a self-regulatory path would be to remove activities from the remit of the authority. At the moment there seems to be no mechanism for that to happen, even if the authority were satisfied, in practice, that some activities were capable of being conducted in a perfectly lawful manner without being licensed and regulated by the authorities. 
 Amendment No. 30 opens up the possibility that the authority could have a deregulatory intent with the consent of the Secretary of State at some future point, as well as responding to changes in circumstances with regard to these activities.

Rosie Winterton: In drawing up the Bill, it was vital to ensure a comprehensive framework so that all sections and interest groups—everyone who contributed to our wide consultation—felt that all aspects were covered. I understand the hon. Gentleman's point, but it is important for the integrity of the Bill that the remit of the authority remains comprehensive in terms of its job regarding the oversight of the keeping, use and disposal of bodies. It would not be right to have the ability to remove aspects of that remit from the Bill. The public and those who had an interest in helping us to put together this important Bill would not want an ability to remove anything from the list of functions. That might undermine confidence in the Bill.
 Over and above that, as the hon. Member for South Cambridgeshire said, we have already highlighted that there is something that we might wish to add to the Bill. I will not go over that again, because I think that he completely understands that point. The approach taken to the regulatory mechanism in the Bill is not unlike that taken in the Human Fertilisation and Embryology Act 1990. We examined that legislation closely when preparing the Human Tissue Bill. In the 1990 Act, the general functions of the authority are set out in section 8 and can be extended under section 8(d). However, as with the Bill before us, the functions cannot be reduced. Similarly, there is no provision to reduce, by means of regulation, the regulatory oversight of the key activities of creating and keeping embryos outside and of storing embryos. The integrity of the scheme is maintained in the same way in the Bill, which is based closely on previous legislation. 
 As I said, we have carefully considered the powers under the Bill. Obviously, there may be instances in which we might wish to add to those, and we have touched on them. However, in terms of maintaining the confidence—and, on many issues, the consensus—achieved in the Bill, it is appropriate to say that the functions can be added to, but not taken away. With those explanations, I hope that the hon. Gentleman will feel able to withdraw his amendment.

Andrew Lansley: I am grateful to the Minister for her reply. I can see that, arguably, there is merit in the remit of the authority being as wide as possible, so as to enable the authority to maintain a system with integrity, as the Minister puts it. However, it still worries me slightly that there is, in effect, a one-way, non-return valve; we can add activities to the remit of the authority, but not remove them.

Rosie Winterton: Obviously it will be possible for the authority to use a lighter touch in particular cases if that were felt to be appropriate. For example, the hon. Gentleman mentions that bio-industries are concerned about burdens. It is important to maintain the powers, but to give some reassurance, a lighter touch could be used in future if necessary.

Andrew Lansley: I understand the Minister's point. Indeed, as far as the licensing regime is concerned, the scope of licensing could be varied under clause 13, which could allow the authority to undertake a self-regulatory approach in a range of activities that could change over time.
 On the basis that that is possible, I shall, if the Committee will forgive me, reflect on the experience of the HFEA over the past 13 years and consider whether it and the Government are going to review its operation, and whether the Government have already undertaken such a review of the powers to see whether any change is required in the legislation. I will consider that further and take advice. Given the Minister's assurances so far, I beg to ask leave to withdraw the amendment. 
 Amendment, by leave, withdrawn. 
 Clause 11 ordered to stand part of the Bill.

Clause 12 - General functions

Andrew Murrison: I beg to move amendment No. 31, in
clause 12, page 9, line 38, leave out from 'remit' to the end of line 39.
 One of the criticisms from outside bodies is that the Bill is complex and difficult to read. I hate to use the word ''bodies'' in this context, but there is no other word that usefully fits the purpose. This simple amendment seeks to remove an area of pedantry around the general functions, about which my hon. Friends and I are concerned. The amendment would remove paragraph (a)(ii) and rely exclusively on the preceding sub-paragraph in stipulating that the Human Tissue Authority should maintain
''a statement of the general principles which it considers should be followed''
 in relation to ''the carrying-on'' of its activities. Although that is a small point, the deletion of that line would improve the way the Bill reads without removing any of its meaning.

Richard Taylor: I join the hon. Gentleman in trying to remove words from the Bill. I, too, cannot see that the paragraph that would be deleted by the amendment adds anything necessary to the clause. I support the amendment.

Rosie Winterton: We would certainly expect the Human Tissue Authority to maintain a statement of general principles as a matter of good corporate governance, as do other arm's-length bodies that are associated with the Department of Health. We would not wish the authority to act in a purely ad hoc way and make up its principles as it went along. We would also expect the authority to take on board current Government policy on arm's-length bodies when it takes up its functions.
 Clause 12(a) requires the Human Tissue Authority to maintain a statement of principles in relation to the activities that it regulates, such as post-mortem practices, anatomical examination, tissue-banking, the use and disposal of tissue and so on. In that way the authority will be able to demonstrate the principles against which it expects activities to be carried out, so that consistency can be maintained in a transparent fashion and stakeholders can recognise the common threads that will run through the various codes and licensing requirements. There has been extensive discussion and agreement about that. 
 At the same time, clause 12 requires the Human Tissue Authority to maintain a set of principles against which it will operate. Declarations might be made, for example, about taking a consultative approach and about guidance being based on best practice. The amendment—and some Committee members—questions whether that is necessary. However, to remove the second element of clause 12(a) would be unfortunate. It is important that the authority be seen to operate consistently and fairly. It would be helpful to all concerned if the principle against which the authority should be tested were known. I understand the points that have been made. However, we feel that this is a useful, practical tool for people to be able to judge the authority against principles not only in theory, but in practice. I hope that the amendment will be withdrawn.

Andrew Murrison: I feel partly reassured. The general point made by the hon. Member for Wyre Forest in support of my amendment is important. As we have been told by a number of interested authorities, this is a complicated Bill. We feel that this deletion would have helped in a small way to make the Bill simpler. However, as this is not a big point, I beg to ask leave to withdraw the amendment.
 Amendment, by leave, withdrawn.

Andrew Lansley: I beg to move amendment No. 5, in
clause 12, page 10, line 11, at end add—
 '(2) In the exercise of its functions, the Authority shall have regard to—
(a) the desirability of securing and maintaining public confidence in the processes for retention, storage and use of relevant material for scheduled purposes;
(b) the desirability of securing the availability of relevant material for the scheduled purposes set out in Schedule 1; and
(c) the desirability of securing that those engaged in the activities related to the scheduled purposes in Schedule 1 are enabled to do so while incurring the minimum necessary burdens of cost and compliance with regulation.'.
 Here we address an issue that might illustrate the differences between the way in which legislation is constructed today and how it was constructed in 1990. I understand that this legislation is reflecting, with some variation, the structure of the Human Fertilisation and Embryology Authority. In 1990, the practice was to set out what a regulatory body had to do. Now, the general practice is to say not only what a body has to do, but what duties it is seeking to fulfil and, more particularly, in addition to those duties what considerations should be reflected in its functions. 
 Regulators nowadays say, ''I do the things that the statute requires me to do.'' The motivation for the amendment is that in the absence of any specification of those considerations, there is a risk that the Human Tissue Authority would simply do the job that is required of it by statute and would be able to devise the manner in which it does that simply on its own account. It might, of course, take account of the debates that we have in Parliament, and it will be obvious to the authority that we are balancing—as we must—the considerations on the one hand of families and patients about the way in which they and their loved ones are dealt with and, on the other, the importance of obtaining the necessary relevant material for human tissues research, education, training and so forth. 
 However, the fact that we say such things in debate does not mean that it is inappropriate to present them in the legislation as considerations to which the authority must have regard. That is the purpose of amendment No. 5. Committee members will know that other regulatory bodies established over recent years have tended to have specific duties that they must meet. The Bill is constructed not around duties, but around a remit, activities and a licensing regime; none the less its duty is to regulate a whole range of activities. It is also true that regulatory bodies are given guidance about what considerations they must have regard to. 
 Under the amendment, the principal considerations that the authority should consider are 
''securing and maintaining public confidence in the processes'' 
that it regulates. It should have regard to 
''the desirability of securing the availability of relevant material for the scheduled purposes''. 
Those two provisions are balanced. There is clearly a worry in the medical and scientific community about the future availability of relevant material. Those two 
 considerations are not in conflict, but they necessarily reflect different aspects of the same outcome. In addition, it should have regard to 
''the desirability of securing that those engaged in the activities related to the scheduled purposes in Schedule 1 are enabled to do so while incurring the minimum necessary burdens of cost and compliance with regulation.'' 
 That provision is slightly different from proposed subsections (2)(a) and (b). Those proposals are clearly implied in the original Bill and in our debates, and there is a risk that—in the absence of a requirement for the authority to have regard to securing the minimum necessary burdens of cost and compliance—the authority could take the view that it had no requirement to do so. 
 However, at no other point does the statute look to the regulator to minimise burdens. It should be the intention of the Government, when establishing regulatory bodies—especially when creating a more comprehensive structure of regulation—to make it clear that one of the ways in which the authority should behave is to secure its objectives with the minimum necessary burden of costs and regulation. Nothing under amendment No. 5 could lead to the conclusion that the authority should compromise its responsibility under the Bill to reduce burdens, but while meeting its obligations, it should minimise those burdens. 
 From my past experience, the amendment is a succinct a way of expressing in legislative form how an authority should think about how it fulfils its functions. As it is a ''have regard to'' amendment, it would not impinge or cut across the responsibilities of the authority. I hope that the Minister considers that the amendment accurately summarises for the authority the considerations that it should have. As regulatory bodies are creatures of statute, it is much better that we set out in the Bill the additional considerations.

Richard Taylor: Paradoxically, having tried to remove words from the Bill under the previous amendment, I am now trying to add words to the Bill under amendment No. 5, which I thoroughly support. It would spell out in one place three vital matters with which the Bill must deal. Obviously, we all want to restore public confidence. The availability of relevant material must be ensured, but I wish to refer to the burden, particularly on clinical staff.
 On Second Reading, the Minister acknowledged that burdens must not be onerous. Let us envisage a busy consultant holding a clinic that is overbooked and running late. Relatives of a recently deceased patient come to the clinic because it is their only opportunity to do so. In such circumstances, he or she would have to break off from duties; in these days of lack of continuity, the consultant might be the only member of the medical staff who has kept in touch with the family throughout the whole difficult illness. Obviously, other staff members, such as nursing staff, can help to explain the consent form, but it must be a senior member of the medical staff who advises the family on completing the form and all its difficult bits. However simple the form is, it will take quite a time to 
 get through. I should like the Human Tissue Authority to bear in mind the tremendous importance of consent being obtained in the least onerous way, with it being possible for senior members of medical staff to be involved despite their other duties.

Rosie Winterton: I certainly understand the points made about the need for the minimum necessary burden of regulation and the point that the hon. Member for Wyre Forest has just made about burdens on front-line staff. Again, I draw him back to previous discussions, when we have said clearly that we want to build on best practice. We know that obtaining consent as he described can be done without being burdensome, which is the right thing to do. We have to make clear that the basis for the Bill is about getting that balance right. It is certainly part of the Government's overall policy—led by the Cabinet Office and the better regulation initiative—to ensure that legislation does not prove to be over-burdensome. The Human Tissue Authority will be regularly reviewed against such standards.
 The effect of the amendment would be fairly limited. A duty to have regard to something that does not require a particular outcome is quite difficult to put in legislation. The word ''desirability'' would also be difficult to define. The difficulty is that, on many occasions, words put in legislation can turn sour as time goes on and the situation develops. Given that the Human Tissue Authority will have to have regard to many factors, listing a few would risk implying that others were less important or that the list was exhaustive. 
 The amendment is well intentioned in terms of supporting research, but it is unnecessary and might turn out to be unhelpful. Again, to make the authority a promoter of regulated activities would remove the balanced and neutral position that the authority must maintain to regulate fairly. Its role is not to promote acquisition, but to create the appropriate conditions for acquiring human material for scheduled purposes.

Andrew Lansley: I must confess that I am worried that the Minister seems to be operating on the basis that we send the regulators away to a neutral environment where they conduct their regulatory activity almost without regard to the purposes for which the regulation was established. We know why the regulation was established. In practice, the authority will read all the materials that led to the establishment of the authority. However, when establishing the authority, Parliament should clarify key purposes for which it is established. When the 20 members meet, their debate can be conducted in a framework, rather than in the neutral, dispassionate way that the Minister envisages.

Rosie Winterton: Our task is to ensure that the legislation provides a comprehensive framework. The amendment would limit the ability to take a balanced view. It would almost imply that some duties are more important than others.

Andrew Lansley: On that point—and it is the second time that the Minister has said that—the amendment is not designed to create any duties for the regulator. Those duties are to regulate the activities under the remit set out in clause 11. The amendment is designed to express considerations that the authority should bear in mind; they are not duties.

Rosie Winterton: Yes, but as I have also said, the addition of such words might be well intentioned but could limit the ways in which the authority can operate. The words of the amendment are not necessarily achievable and could be challengeable. That is the problem that we have with it. Clause 12(d) gives the authority the task of providing information about regulated activities to the public and to persons carrying on such activities. Through establishing a balance of lay and non-lay members of the authority, we have tried to improve public confidence in obtaining and using human tissue.
 The purpose of the Bill is not only to set out the principles of consent, but to provide a framework in which research can take place. That can be done only as part of a regulated environment. I understand the hon. Gentleman's points, but his amendment would not achieve what he is trying to do. Therefore, I hope that he will withdraw the amendment.

Andrew Lansley: When the Minister says that something is well intentioned, it sometimes sounds like an insult. The amendment is not only well intentioned; it is an accurate reflection of the considerations that Parliament would want to be included. It is not an exhaustive list, and there are dangers in trying to present it as such. It is a fair summary of the principal considerations that Parliament would want the authority to have in mind.
 The Minister's comment that the amendment could be a hostage to fortune is an arguable proposition. I find it difficult to conceive of circumstances in which the authority would not balance the desirability of securing public confidence and available material with the minimum necessary burdens. We could have written that in a much longer form, but the objective was to reflect those purposes in as short a form as we could. 
 I suspected that the Minister would argue that the considerations were so self-evident that the authority would not need guidance on them. Without paragraph (c) of the amendment, there is a danger that when the authority comes to consider its activities and somebody in the HTA argues strongly that things should be done in a less burdensome rather than more comprehensive way, there will always be—because of the nature of the statutory regime—a tendency to go down the route of comprehensive regulation rather than what one might refer to as appropriate regulation. 
 It is all very well for the Minister to say—we shall discuss this point in one particular respect later—that the authority will be reviewed by the Better Regulation Task Force, but there is nothing in the Bill, or any other statute for that matter, that means that the authority must have any regard for the BRTF's views. 
 It can review all it likes, but the authority can say, ''We have a statutory responsibility, and in meeting that we cannot vary our decision, because we are set up to be comprehensive.'' Precisely the things that the Minister says about the comprehensive nature of the regime and the necessity for its integrity are likely to lead in the long run to a comprehensive and burdensome way of addressing the authority's responsibilities. 
 I focus on that point because paragraph (c) is the part of the amendment that is most likely to go out of the window. It is probably fair to say that paragraphs (a) and (b)—concerning public confidence on the one hand and securing availability on the other—are matters that any authority trying to meet such responsibilities would consider. Sometimes, it does no harm to recognise in an authority's statutory form the balance that it is required to strike. Although we will hold the authority accountable by examining what it does and ensuring that its activities are transparent, it should be aware that we must do so against the background of its requirement to try to balance those considerations. As the word ''desirability'' is not susceptible to definition, it would be subject to little challenge in the way that the Minister contends. Challenging the decisions of the authority by reference to its not having had regard to one of those considerations would in effect mean having to go to judicial review to say that absolutely no regard was had to the issue. If the authority made decisions without regard to any of those factors, it ought rightly to be subject to review because they are the factors and purposes for which it was established. If it leaves them out and is subject to challenge, so be it. 
 I am not in the least persuaded by the Minister's argument that the proposal is inappropriate. Her argument seemed to be that when we set up regulatory bodies it is very tiresome and potentially risky to tell them what they ought to do. That seems to me to be what we are here to do. During the last Session, I was concerned with the establishment of Ofcom, the new water regulatory body and the independent regulator for foundation hospitals. I would have to go away and look this up, but in none of those cases do I recall that, having defined what the regulator was intended to regulate, Parliament did not trouble itself to say why the regulator was doing it, what its duties were and what considerations it should have in mind. To varying degrees, that is what Parliament does when it sets up regulators. Therefore, I am not persuaded. 
 It is not my objective to divide the Committee. Wherever we can, I want us to proceed by consensus, so I will not press the amendment to a Division. However, the Minister may be sure that before Report I will marshal examples of the many cases in recent years in which the Government have set out not only the functions of a regulator, but the duties and the considerations to which a regulator should have regard. I will do that to demonstrate that such proposals are not generally regarded as a hostage to fortune. The Minister may have adopted the structures of the Human Fertilisation and Embryology Authority from 1990, but that has been overtaken by 
 the way in which we currently adopt best practice in setting up regulatory bodies. Unless the Minister chooses on Report to adopt some of that through Government amendments, we will return to the matter. However, I beg to ask leave to withdraw the amendment. 
 Amendment, by leave, withdrawn. 
 Clause 12 ordered to stand part of the Bill.

Clause 13 - Licence requirement

Andrew Murrison: I beg to move amendment No. 156, in
clause 13, page 10, line 27, at end insert 'normally requiring consent'.

Alan Hurst: With this it will be convenient to discuss the following:
 Amendment No. 32, in 
clause 13, page 10, line 32, leave out subsection (3).

Andrew Murrison: We deal now with licence requirements—in the context of amendment No. 156, the licence requirements for the storage of body parts. We have already heard about the need to clarify aspects of the Bill, and my hon. Friends and I feel that some clarification of subsection (2)(e)(ii) is due. Such clarification would be helped by the amendment, which would exclude part 2 of the schedule 1 purposes. At the moment, that is not clear. It would be helpful if it were very clear that the Under-Secretary does not intend those part 2 purposes to require licensing, and our amendment would achieve that.
 Amendment No. 32 is simple. I expect that the Under-Secretary will perceive a theme running through our amendments: we seek to clip the powers of the Secretary of State. Amendment No. 32 would do that. Meanwhile, will the Minister comment on the circumstances that would result in the exception referred to in subsection (3)?

Stephen Ladyman: It is important to restate the principle behind the way in which we have structured the Bill. The Bill intends to provide a strong statutory framework, with as much flexibility as possible in it. That is why we have chosen to do certain things through regulation and best practice guidance, rather than including them in the Bill. I fear that the hon. Gentleman's amendments go against that principle.
 For example, amendment No.156 would limit the licensing requirement for tissue storage to storage for part 1 purposes. Storage for use for purposes in part 2 of schedule 1 would not be licensable. Under subsection (2)(e)(ii), the licensing requirement for tissue storage applies to living and post mortem tissue. The hon. Gentleman's amendment would mean that tissue from living patients would not need consent of use for part 2 purposes, and might not need strict regulation. One might argue that point. However, his amendment would also exempt from the licensing requirement the storage of post mortem tissue for part 
 2 purposes. Such tissue is subject to consent requirements, and for that reason we want it to be subject to the licensing scheme. In many cases, living and post mortem tissue will be kept in the same institutions; it would be impractical to operate separate regimes for different types of tissue. 
 The Human Tissue Authority will give guidance under clause 23 on the storage for use of all such tissue, and it will establish appropriate licensing and inspection mechanisms for the various activities that fall under subsection (2). Given our approach of maintaining flexibility in the statutory framework, the Human Tissue Authority will be able to apply different approaches in different circumstances, depending on the nature or scale of the activity. For example, it would exercise a more rigorous overview of safety and quality matters in tissue storage for human application than in tissue storage for other uses. 
 It is important to recognise the significance of human tissue and that, whether it is from living patients or from the deceased, it should be subject to common principles and approaches. For that reason, it is all subject to the appropriate oversight from the Human Tissue Authority. To remove from the licence requirement all tissue for all part 2 purposes would risk lack of oversight in potentially sensitive areas of activity. I hope that, with that explanation, the hon. Gentleman will see fit to withdraw his amendment.

Andrew Murrison: I am very grateful to the Under-Secretary for that reply, but he has not addressed amendment No. 32, and he may want to do so. In respect of amendment No. 156, I am partially reassured. Having earlier accused the Under-Secretary of pedantry, I must turn that on myself, because the part 2 scheduled purposes would almost certainly be covered by a licence that was provided for under part 1.

Stephen Ladyman: I am sorry that I did not clarify our position on amendment No. 32; I thought that I had explained it in my introductory remarks. We want to achieve the highest possible ethical standards in respect of all of our operations, including those that involve tissue banks. We believe that we can establish those ethical standards, but within a strong statutory framework, and the amendment is unnecessary because it would not allow us flexibility within that framework.

Andrew Murrison: I am grateful for that clarification, which is fine. The part 2 scheduled purposes would be carried out by licensed persons on licensed premises because they would also be engaged in part 1 scheduled purposes. I think that the Under-Secretary is saying that licensing would not be viewed as addressing part 2 purposes principally, but as addressing part 1 purposes, given that those who are operating under the licence would be participating in part 1 purposes on premises that are principally licensed because of the need to conduct those part 1 purposes. That is a terribly twisted way of putting it, but I am sure that the
 Under-Secretary understands me. If that is the case, I am happy to beg to ask leave to withdraw the amendment.
 Amendment, by leave, withdrawn. 
 Clause 13 ordered to stand part of the Bill.

Schedule 3 - Licences for the purposes of section 13

Question proposed, That this schedule be the Third schedule to the Bill.

Andrew Lansley: I want to raise two points. The first relates to the structure of fees. Paragraph 4(f) of schedule 3 refers to the power given to the authority to seek fees. I think that at a later point fees can be required to be paid along with an application. There is also the power to pay additional recurrent fees at such time as the authority can direct. As I recall, a power of that kind can be expressed as it has been, or it can be expressed in the same form but with a requirement that the fees should not exceed the costs incurred. The fees should therefore be reflective of costs incurred. It would be helpful if the Under-Secretary assured us that the power, although expressed in this form, will be limited to the reimbursement of costs incurred by the authority in undertaking the licensing process.
 Paragraph 2 reads: 
 ''A licence shall not authorise the carrying-on of more than one activity to which section 13 applies.'' 
As I understand it, the licensing process means that a pathology laboratory that is responsible for post mortems and the removal of material, not only for post mortem purposes but for subsequent use for other scheduled purposes, and also a premise where material is stored for subsequent use, will be required to have three licences. I want to be sure that that is the case, as I am unsure why the Government consider it necessary to have three licences when one might suffice. I should like to be reassured about the burdens that might accrue from having to be licensed that number of times for what is, from the practitioner's point of view, one set of activities and one set of material. 
 Paragraph 7 gives a power to revoke licences. If I recollect correctly, this is different from the structure of the HFEA's power in relation to its own licensed clinics. Will the Under-Secretary tell the Committee how it is different? I also recollect that the HFEA anticipates that, in its submissions to the review of the 1990 Act, one of its intentions will be to give itself sanctions—short of revoking the licence—to impose on those persons who are failing fully or appropriately to discharge their responsibilities under the licence. I am not sure that I can see that here: the power to revoke a licence is here, as is the power to impose conditions when a licence is issued, but there are no intermediate steps by which the authority could undertake enforcement, short of revoking a licence. 
 The revocation of a licence could be quite a draconian power in cases of relatively minor breaches of the licence requirement. I assume that we are not getting into the territory of clause 22, where the licence 
 requirement has been breached altogether: this would apply to some one operating under the licence in good faith, or who is simply failing to meet their obligations as the authority would wish. There does not seem to be any process of iteration in which the authority can say to the licence holder, ''You may not be meeting the conditions appropriately—we want you to do this and we have sanctions to require you to do it, short of revoking your licence.'' That may be excessive. If we are going to review the HFEA at some point—perhaps a couple of years hence—I should be sorry if we had incorporated in the Bill a structure based on the HFEA which subsequently turned out, in the HFEA's experience, to be inappropriate.

Stephen Ladyman: So far as the licence fee is concerned, the principle on which we are proceeding is only to allow cost recovery. One must accept also that the Government would not wish to subsidise regulatory bodies. Those operating or applying for licences must expect to cover the full cost of managing the licence process. We do not intend that the costs will go beyond the cost of recovering the licence fee.
 As for the different licences that may be required, a licence can cover only one activity, so the application can be covered by a single process. Applying for several activities can be done on one form in one stage, but several licences might be issued. That will have benefits for the organisation, as it may want different activities to be managed separately. Its internal structure might mean that it is better to have different oversight of different activities to ensure compliance with the Bill.

Andrew Murrison: Will the Under-Secretary confirm that just one licence fee would be involved?

Stephen Ladyman: Yes, in that, in setting that fee, we will be recovering the full cost of the application. However, it will not be a mechanism by which people can avoid the costs, if that was what the hon. Gentleman was looking for.
 On the substantive point about he difference between this Bill and the Human Fertilisation and Embryology Act 1990, the hon. Member for South Cambridgeshire has a good point: there should be a mechanism short of revocation. One question is whether that requires sanctions short of revocation or whether it should be a matter of providing advice. In the latter case, whether or not that advice is accepted and acted on could inform the process of revocation. 
 If an organisation was not complying, it would be appropriate for the authority to explain to the organisation how it was not complying and what it was doing. In deciding whether to revoke the licence it would also want to take into account whether the organisation responded to that advice. Although there may not be a sanction short of revocation, I am not sure that the hon. Gentleman is right to say that such a sanction is needed. The response to any advice would be important.

Andrew Lansley: I, too, am unsure whether sanctions are required. Another option could be for the authority to have the power to impose conditions on licences, not only when they were granted but subsequently. I am not sure whether paragraph 5 allows that, but that could be a suitable mechanism.

Stephen Ladyman: It is my understanding that, in paragraph 8(5), the schedule allows that to happen. The authority may also provide directions when it is in discussions with an organisation that might not be living up to best practice guidance or the high standards that have been set.
 Having given those explanations, I hope that the hon. Gentleman agrees that the issues that he identified have been covered and that schedule 3 will be an important part of the Bill. 
 Question put and agreed to. 
 Schedule 3 agreed to. 
 Clause 14 ordered to stand part of the Bill.

Clause 15 - Duty of the designated individual

Evan Harris: I beg to move amendment No. 177, in
clause 15, page 11, line 16, after 'on', insert
'to do all that is practicable'.

Alan Hurst: With this it will be convenient to discuss the following:
 Amendment No. 84, in 
clause 15, page 11, line 18, leave out paragraphs (a) and (b).

Evan Harris: This is a probing amendment to clarify the position of the designated individual who does all that is practicable to comply with the terms of the licence but, for reasons beyond their control, is unable to comply, or ensure that people working with their authority comply, with the licence. I want to clarify whether there will be natural justice. How does the Under-Secretary envisage people being able to argue that they did their best to ensure that activities were undertaken in conformity with the licence?

Andrew Murrison: Amendment No. 84 is barking up the same tree as that of the hon. Member for Oxford, West and Abingdon, but it is a little stronger in its probing, because it would delete part of the Bill. Hospitals and many organisations involved in medical research will experience difficulty with supervision and the burdens that will be placed on supervisors. In practice, many such people will be remote from the individual who holds the licence, and it will be exceptionally difficult to achieve the kind of supervision that the Under-Secretary envisages.
 The definition of suitable practices and persons is not given. I suspect that the Under-Secretary will say that that will be explored in the codes of practice, but that would leave it open for the word ''suitable'' to be interpreted in an undesirable way. If we are to put an onus on individuals who supervise, we need to give 
 them a clear steer—I suggest that we do so in the Bill—about what we mean by the suitability of persons who may operate as subordinates to the licensee, and the suitability of practices. Paragraphs (a) and (b) are unhelpful in that they fail adequately to define, even for the casual reader, what is intended. For that reason alone, they must be candidates for deletion.

Stephen Ladyman: I do not agree with the hon. Gentleman. It is true that the person who applies for the licence need not be the designated individual. In my experience, which is of working in medical research environments, the two would be different people, because it would not be appropriate for people such as the head of department, the professor or the dean of the medical school to be the designated individual. They would neither have the necessary routine access to areas where procedures are carried out, nor be in and out of people's laboratories on a sufficiently regular basis. They might no longer have even the necessary hands-on experience to be the designated individual.
 It would be beholden on the person who applied for the licence to ensure that the designated individual had the experience, time and access to do the job properly, because if they did not, the licence would probably be revoked. That would not be in the interests of the head of department, dean or professor. I say that as someone who, in all my career working in medical research environments, has come across very few heads of departments that I would not have wanted to see banged up. I feel strongly that there are few deans, vice-chancellors or professors who would not be improved by a good, solid dose of porridge. However, I must disappoint the post-docs of this world by saying that I do not think that the Bill will serve that purpose, because it has been devised flexibly and sensibly to allow the separation of functions between the person who applies for the licence and the designated individual. In my experience, the designated individual in most research environments will probably be the laboratory manager, because they have the most experience of what is going on in the organisation. 
 The Bill has been sensibly drafted. If we were to go down the route suggested by the hon. Gentleman, it would mean being far more restrictive, and imposing far greater burdens on the heads of departments and professors, which is much more likely to land them in trouble. I certainly would not advise the Committee to agree to the amendment. 
 As to the other suggestion, it is important that we maintain the principle in the Bill that the designated individual has to be a person with the experience, the access and the supervisory authority to carry out his functions appropriately. Were we to accept the amendment tabled by the hon. Member for Oxford, West and Abingdon and insert 
''to do all that is practicable'', 
the individual would have to decide for himself what was practicable, rather than do everything that he could to ensure that the functions were carried out properly. 
 The designated individual should be in a position to identify areas in which he does not have the knowledge to ensure that the provisions are being properly enforced, and he should be able to call a halt to the proceedings until he is assured that things are being done in accordance with the law. It would set a poor precedent if he could just assume that things were going on in dark corners of which he was not aware. Having said that, if questions were to be asked, it would be a legitimate defence for the designated individual if he carried out his duties appropriately, understood the Bill himself, ensured that everyone concerned understood the licence conditions under which they were acting and understood what was required of them, and if he supervised them properly and ensured that their work was quality assured within the terms of the Bill. I urge the hon. Gentleman to withdraw his amendment.

Evan Harris: In light of the Under-Secretary's comments I beg to ask leave to withdraw the amendment.
 Amendment, by leave, withdrawn. 
 Clause 15 ordered to stand part of the Bill. 
 Clause 16 ordered to stand part of the Bill.

Clause 17 - Appeals committees

Question proposed, That the clause stand part of the Bill.

Andrew Lansley: I understand that the decisions that are taken by the authority are those of the authority as a whole, therefore every member is equally responsible for them. However, although I would not expect it to be the subject of a change in the Bill, can the Under-Secretary assure us, for reasons of natural justice, that in practice the appeals committee would, whenever possible, be constructed of members who did not have a specific function in making the original decision that was to be the subject of an appeal? Within the obvious constraint of their all having been responsible for the decision, can we achieve that objective?

Evan Harris: I am grateful to the hon. Gentleman for raising the setting up of appeals committees because it arose under the issue of appeals to professional regulatory bodies. I understand that the General Dental Council recently changed its regulations to ensure that they were compliant with the Human Rights Act 1998 and that members of the appeals committee are not members of the GDC. The appeals committee is therefore made up of people appointed for the purposes of appeals by the main authority—in this case, the GDC.
 That has been set up as a model for other regulatory authorities. I know that that had to be done in response to questions about Human Rights Act compliance and fair trial. The suggestion made by the hon. Member for South Cambridgeshire may not go far enough. I should be grateful if the Under-Secretary 
 could reassure us that there is legal support for leaving the Bill as it stands or for taking on board the hon. Gentleman's suggestion.

Stephen Ladyman: I can give both hon. Gentlemen the assurances that they seek. We have tried to ensure that the Bill and the procedures to be followed are compliant with the Human Rights Act. I understand that the conditions set by the hon. Member for South Cambridgeshire would be a requirement of
 compliance with that. There should not be a conflict of interests. We will reflect on the points that both hon. Gentlemen have made and, if necessary, we will discuss them further on Report.
 Question put and agreed to. 
 Clause 17 ordered to stand part of the Bill. 
It being twenty-five minutes past Eleven o'clock, The Chairman adjourned the Committee without Question put, pursuant to the Standing Order. 
 Adjourned till this day at half-past Two o'clock.